Status:
RECRUITING
Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)
Lead Sponsor:
Emory University
Collaborating Sponsors:
Laboratoire Français du Fractionnement et des Biotechnologies (LFB BIOTECHNOLOGIES)
Conditions:
Glanzmann Thrombasthenia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study is evaluating an investigational drug, eptacog beta (EB), for the treatment and prevention of acute bleeding episodes in people with Glanzmann Thrombasthenia, a rare inherited bleeding diso...
Detailed Description
This study aims to investigate eptacog beta (EB), a new form of recombinant activated factor VIIa, for bleeding management in persons with Glanzmann thrombasthenia regardless of platelet refractorines...
Eligibility Criteria
Inclusion
- Adult or Pediatric persons with inherited Glanzmann thrombasthenia (see diagnostic criteria below)
- Severe bleeding phenotype
- Adequate hepatic function
- Adequate renal function
- Adults subject (≥18 years of age) or caregiver (parent or legally authorized representative) for minor subjects, subjects with cognitive impairment, or subjects with impaired decision-making capacity have provided written informed consent, and the participant has given consent/assent (if applicable)
- Ability to speak, read, and understand the English language
Exclusion
- Thrombocytopenia (platelet count \< 100k)
- Acquired Glanzmann thrombasthenia secondary to autoimmune disease, malignancy, or medication
- Inherited or acquired bleeding diathesis other than Glanzmann thrombasthenia
- Have a history of venous or arterial thrombotic event within 2 years of study enrollment
- Active malignancy
- Known or suspected hypersensitivity to rabbits, rabbit protein, other forms of rFVIIa, or to any of the EB excipients
- Have received an investigational drug within 30 days or within 5 half-lives of that investigational drug (whichever is longer) or are expected to receive such a drug during participation in this study
- Be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitor properties for the duration of the study
- Be using or administered anticoagulant agents for the duration of the study
- Have any life-threatening disease or other disease or condition which, according to the investigator's judgement, could imply a potential hazard to the patient, or interfere with the study participation or study outcome
- Use of systemic immunomodulators at enrollment or planned use during the study
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT07136857
Start Date
October 2 2025
End Date
December 1 2026
Last Update
December 1 2025
Active Locations (1)
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1
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329